Effects of Visnadin, Ethyl Ximeninate, Coleus Barbatus and Millet in Emulgel on Sexual Function in Postmenopausal Women

Effects of Visnadin, Ethyl Ximeninate, Coleus Barbatus and Millet in Emulgel on Sexual Function in Postmenopausal Women With Vulvovaginal Atrophy, a Randomized Controlled Trial

This clinical trial, a double blind randomized controlled trial, is conducted to determine the effects of daily topical visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel on sexual function in postmenopausal women with vulvovaginal atrophy within 8-week of treatment. We compare the active ingredient in emulgel to the emulgel only. We also evaluate the improvement of the vulvovaginal atrophy symptoms in postmenopausal women, the safety and the tolerability of visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel. This study is conducted in the Menopause Clinic and the Gynecology Clinic, King Chulalongkorn Memorial Hospital, Bangkok, Thailand.

Study Overview

• Status: Recruiting
• Conditions: Vulvovaginal Atrophy; Postmenopausal Atrophic Vaginitis; Female Sexual Function
• Intervention / Treatment: Other: Visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel; Other: Emulgel-only

Detailed Description

Topical visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel is a cosmetic product. Visnadin is an active ingredient which has the vasodilator effect and improve blood flow to female vulvovaginal area. This will improve lubrication from increase Bartholin's gland secretion. As the clitoral blood flow increase, the sexual response could be improved. The ethyl ximeninate, coleus barbatus and millet are plant extract which have moisturizer, anti-inflammation and antioxidant effects. Our hypothesis is a daily topical visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel could improved sexual function and vulvovaginal atrophic symptoms in postmenopausal women with vulvovaginal atrophy.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sukanya Chaikittisilpa, MD,MSc; Phone Number: +66915615415; Email: sukanya.c@chula.ac.th
• Study Contact Backup: Name: Nalina Orprayoon, MD; Phone Number: +66909908440; Email: nalina.o@chula.ac.th

Study Locations

• Thailand
  • Bangkok
    • Pathum Wan, Bangkok, Thailand, 10330
      • Recruiting
      • Faculty of Medicine, Chulalongkorn University
      • Contact: Sukanya Chaikittisilpa; Phone Number: +66915615415; Email: sukanya.c@chula.ac.th
      • Contact: Nalina Orprayoon; Phone Number: +66909908440; Email: nalina.o@chula.ac.th
      • Principal Investigator: Sukanya Chaikittisilpa, MD,MSc
      • Sub-Investigator: Nalina Orprayoon, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women age 45-65 years old
• BMI 19-29 kg/m2
• Menopause or removal of both ovaries more than 1 year
• Has moderate to severe vulvovaginal atrophic at least 1 symptom
• Has sign of vulvovaginal atrophy
• Vaginal pH ≥ 5
• Has sexual intercourse at least 1 time/month

Exclusion Criteria:

• Hormonal use within 3 months
• Use vaginal estrogen/ moisturizer within 3 months
• Use aromatase inhibitor/tamoxifen within 3 months
• Has vaginal bleeding within 6 months
• Acute or chronic urinary tract infection
• History of radiation therapy at vulvovaginal and pelvic area
• History of Diabetes mellitus or Cardiovascular disease
• History of neurosis or psychosis
• History of vulvovaginal cancer
• History of smoking more than 20 cigarettes/day
• History of alcoholic drink/ drug abuse
• History of visnadin, ethyl ximeninate, coleus barbatus and millet allergy
• Has disease of vulva

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Group; Apply small amount of topical visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel on mucosal surface of vulva included clitoris every day before bedtime for 8-week period.	Other: Visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel; Topical product, apply small amount on mucosal surface of vulva included clitoris once daily
Placebo Comparator: Placebo Group; Apply small amount of topical emulgel-only on mucosal surface of vulva included clitoris every day before bedtime for 8-week period.	Other: Emulgel-only; Topical placebo product, apply small amount on mucosal surface of vulva included clitoris once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sexual function	Female Sexual Function Index (FSFI) The full scale (overall) score of the FSFI can be derived from the six domain scores; desire, arousal, lubrication, orgasm, satisfaction and pain. The minimum value is 2.0 and maximum value is 36.0, and the higher scores mean a better outcome.	8-week
Vulvovaginal atrophic symptoms score	4-likert scale; 0 = no symptom, 1= mild symptom, 2 = moderate symptom, 3 = severe symptom The minimum is 0 and maximum value is 4, and the higher scores mean a worse outcome.	8-week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse event and tolerability	Possible adverse event of therapeutic use	8-week

Collaborators and Investigators

• Sponsor: Chulalongkorn University
• Investigators: Principal Investigator: Sukanya Chaikittisilpa, MD,MSc, Chulalongkorn University

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2021
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): November 25, 2024

Study Registration Dates

• First Submitted: October 6, 2020
• First Submitted That Met QC Criteria: October 6, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Postmenopausal women; Genitourinary Syndrome of Menopause; Vulvovaginal atrophy; Female sexual function; Visnadin
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Vaginal Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Vaginitis; Atrophic Vaginitis; Atrophy
• Other Study ID Numbers: MRU20200001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No